Evidence map›Paper›PMID 35717200›Full record

ArticleTrials2022

Effect of new biological patch in repairing intrauterine adhesion and improving clinical pregnancy outcome in infertile women: study protocol for a randomized controlled trial.

Wen-Juan Pang, Qing Zhang, Hai-Xia Ding, Ning-Xia Sun, Wen Li

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Wen-Juan PangReproductive Medicine Center, Second Affiliated Hospital of Naval Medical University, No. 415 of Fengyang Road, Huangpu District, Shanghai, 200003, China.
Qing ZhangInternational Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, No. 910 of Hengshan Road, Xuhui District, Shanghai, 200030, China.
Hai-Xia DingInternational Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, No. 910 of Hengshan Road, Xuhui District, Shanghai, 200030, China.
Ning-Xia SunReproductive Medicine Center, Second Affiliated Hospital of Naval Medical University, No. 415 of Fengyang Road, Huangpu District, Shanghai, 200003, China. sunningxiaa@126.com.
Wen LiInternational Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, No. 910 of Hengshan Road, Xuhui District, Shanghai, 200030, China. liwenlwliwen@163.com.
Second Military Medical University · CNShanghai Jiao Tong University · CNInternational Peace Maternity & Child Health Hospital · CN

Funding

Clinical Research Plan of SHCD SHDC2020CR3054B
6 · The paper itself

Abstract

backgroundEndometrial fibrosis caused by intrauterine adhesion (IUA) can lead to hypomenorrhea, amenorrhea, and even infertility and abortion. The postoperative recurrence rate of severe IUA remains high, giving rise to low pregnancy rates. An extracellular matrix (ECM) scaffold, a new biological material that can promote cell proliferation and differentiation at lesions, has been widely used in general surgery and neurosurgery. The present study applied ECM scaffolds in obstetrics and gynecology for the first time to improve endometrial fibrosis, repair severe IUA, and improve pregnancy outcomes for infertile patients.

methodsThis paper presents a prospective randomized single-blind controlled superiority study of infertile women aged ≤40 years with IUA. According to the scoring criteria for IUA established by the American Fertility Society, patients with moderate or severe IUA were randomized into two groups at a ratio of 1:1; patients in the experimental group were treated with an ECM scaffold (small intestinal submucosa [SIS]) + intrauterine balloon, while patients in the control group were treated with an intrauterine balloon only. A hysteroscopic examination of adhesion repair was performed again after 2 months of postoperative hormone replacement therapy. Endometrial tissue was sampled during the two operations, and immunohistochemistry was used to observe endometrial and microvascular proliferation. After thawing and resuscitation, a postoperative frozen embryo transfer was performed on the participants in both groups, and their endometrial thickness, intrauterine volume, endometrial vascularization flow index, endometrial flow index, and uterine artery blood flow resistance were evaluated by 3D ultrasonography. The rates of embryo implantation, clinical pregnancy, and early spontaneous abortion were observed. DISCUSSION: The ECM scaffold (SIS) + intrauterine balloon method was able to repair endometrial fibrosis and improve IUA. This new technique represents a novel treatment method for improving the pregnancy outcome of infertile patients with moderate/severe IUA.

trial registrationChinese Clinical Trial Register ChiCTR2100052027 . Registered on October 14, 2021.

Indexed as

Infertility, FemaleUterine DiseasesAdultEndometriumEquivalence Trials as TopicFemaleHumansPregnancyPregnancy OutcomeProspective StudiesRandomized Controlled Trials as TopicSingle-Blind MethodTissue AdhesionsEndometrial fibrosisExtracellular matrixIntrauterine adhesionIn vitro fertilization–embryo transfer

Identifiers

PMID35717200
PMCPMC9206332
OpenAlexW4283066719

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.